| CTRI Number |
CTRI/2024/03/063818 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL TRAIL TO STUDY THE EFFICACY OF TWO BLOCKS TRANSVERSE ABDOMINIS PLANE AND QUADRATUS LUMBORUM BLOCK IN PATIENTS UNDERGOING CESAREAN SECTION . |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF ULTRASOUND GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK VERSUS QUADRATUS LUMBORUM BLOCK ON POSTOPERATIVE PAIN IN PATIENTS UNDERGOING LSCS:A RANDOMISED CONTROL STUDY. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR T N Rakshitha |
| Designation |
Postgraduate Resident |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore Bangalore KARNATAKA 560002 India |
| Phone |
9886786768 |
| Fax |
|
| Email |
rakshithanagesh8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MADHUMALA H R |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore Bangalore KARNATAKA 560002 India |
| Phone |
9886786768 |
| Fax |
|
| Email |
drmadhumala@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR T N Rakshitha |
| Designation |
Postgraduate Resident |
| Affiliation |
Department of Anesthesiology Bangalore Medical College and Research Institute |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore Bangalore KARNATAKA 560002 India |
| Phone |
9886786768 |
| Fax |
|
| Email |
rakshithanagesh8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Bangalore Medical College and Research Institute
KR Market Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MADHUMALA H R |
Bangalore medical college and research institute |
Department of Anaesthesiology
Bangalore medical college and research institute KR market road -560002
bangalore
Karnataka Bangalore KARNATAKA |
9886786768
drmadhumala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% bupivacaine in ultrasound guided quadratus lumborum plane block. |
Single shot of 20 ml of 0.25% bupivacaine will be administered under ultrasound guided quadratus lumborum plane block in patients undergoing cesarean section after one hour of spinal anaesthesia |
| Intervention |
0.25% bupivacaine in ultrasound guided transverse abdominis plane block |
Single shot of 20 ml of 0.25% bupivacaine will be administered under ultrasound guided transverse abdominis plane block in patients undergoing cesarean section after one hour of spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients who are willing to give consent.
2)Patients of normal singleton pregnancy beyond 36 weeks gestation posted for caesarean section.
3)Patients belonging to ASA II
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The postoperative analgesic efficacy of ultrasound guided transverse abdominis plane block and quadratus lumborum block by visual analog scale (VAS). |
The postoperative analgesic efficacy of ultrasound guided transverse abdominis plane block and quadratus lumborum block by visual analog scale (VAS). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1)to calculate the opioids used by the patients postoperatively. |
to calculate the total dosage of opioids used within 72 hours |
|
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Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cesarean section is the
most common surgical procedure done in
obstetrics. Effective postoperative analgesia help parturient with early
recovery, breastfeeding, and ambulation. Opioids are mainly used for postoperative
pain management, but the limitation of opioids includes respiratory depression
causing discomfort to the parturient, other insignificant side effects include
itching, urinary retention, pruritis, and GI upset. The transverse abdominis plane block
has a multimodal approach in post-operative pain management. In the transverse
abdominis plane block, the local anesthetic solution is injected between the
internal oblique and transverse abdominis muscle. Thoracolumbar nerves arise
from T6- L1 spine roots and pass-through this plane and supply sensory nerves
to the anterolateral abdominal wall. Quadratus lumborum is a posterior
abdominal wall block that allows the spread of local anesthetic solution behind
quadratus lumborum muscle and extends beyond the thoracolumbar fascia middle
layer into a triangular space called the interfascial triangle. This space is
near sympathetic fibers which extend to the thoracic paravertebral space. Ultrasound
imaging has renewed interest in peripheral nerve blocks reducing the risk of
needle contact with critical structures. In USG
guided imaging, we can directly visualize the layers of muscles, the advancing
needle and the injected fluid. The advantages are technical
simplicity, high analgesic effectiveness, opioid sparing, long duration and
minimal side effects. Ultrasound guided Transverse abdominis
plane block and Ultrasound guided quadratus lumborum decrease the acute and
chronic postoperative pain following cesarean section. As there are only a few studies done on
ultrasound guided transverse abdominis plane block and ultrasound
quadratus lumborum block in cesarean
patients, the study is designed to assess the efficacy of ultrasound guided
transverse abdominis plane block and quadratus lumborum block for postoperative
analgesia following cesarean section. |